ADJUNCT VITAMIN A THERAPY FOR TUBERCULOSIS AND HIV/AIDS

描述(改编自摘要)：到2000年，一些估计 13.8%的艾滋病毒携带者将与 结核病(TB)。尽管结核病化疗有效，但死亡率 保持在极高的水平，而且没有简单、廉价的干预措施， 已知会增加感染艾滋病毒和结核病的成年人的存活率。在此之前 抗生素疗法的发现，以鱼肝油形式存在的维生素A， 维生素A的有效来源，是一种以上结核病的标准治疗方法 一百年了。维生素A是正常免疫功能所必需的，而且 补充维生素A已被许多国家采用，以减少 儿童死亡率。在艾滋病毒感染期间，维生素A缺乏一直是 与美国、海地、马拉维和 乌干达。研究人员的初步研究表明，90%的成年人患有 艾滋病毒和结核病缺乏维生素A。然而，维生素A是否 补充剂是否会降低这些患者的死亡率尚不清楚。这个 这项研究的目的是确定每天的维生素A 与结核病化疗同时服用的补充剂将减少 感染艾滋病毒和结核病的成年人的死亡率。调查员提议进行一项 每日随机、双盲、安慰剂对照临床试验 Zomba 1100名HIV感染成人肺结核患者的维生素A治疗 马拉维，一个艾滋病毒和结核病高流行的人口。死亡 在这些感染艾滋病毒和结核病的成年人中，24个月前的感染率为45% 结核病化疗。成人将接受标准的结核病化疗(异烟肼， 利福平、链霉素、吡津酰胺)，紧随其后 异烟肼和乙胺丁醇在接下来的六个月内)和附件 同时接受维生素A或安慰剂治疗。参与者将是 在注册后的24个月内对重要事件进行跟踪。如果是附属的 维生素A疗法被证明可以降低感染艾滋病毒和结核病的成年人的死亡率， 这种干预将具有已知的最高成本效益比之一， 因为辅助性维生素A疗法每人大约花费80美分， 可以很容易地与结核病化疗结合起来。

DESCRIPTION (adapted from the Abstract): By the year 2000 some estimate that 13.8 % of all individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available, known to increase survival in adults with HIV and TB. Prior to the discovery of antibiotic treatment, Vitamin A in the form of cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB for over one hundred years. Vitamin A is essential for normal immune function, and Vitamin A supplementation has been adopted by many countries to reduce mortality in children. During HIV infection, Vitamin A deficiency has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. The researchers preliminary studies show that >90 % of adults with HIV and TB are Vitamin A-deficient. However, whether Vitamin A supplementation will reduce mortality in these patients is not known. The objective of the study is to determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB. The Investigator proposes to conduct a randomized, double-masked, placebo-controlled clinical trial of daily Vitamin A therapy for 1100 HIV-infected adults with pulmonary TB in Zomba, Malawi, a population with a high prevalence of HIV and TB. The mortality rate is 45 % by 24 months in these adults with HIV and TB who have undergone TB chemotherapy. Adults will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first two months, followed by isoniazid and ethambutol for the following six months) and adjunct Vitamin A or placebo therapy at the same time. Participants will be followed for vital events for 24 months after enrollment. If adjunct Vitamin A therapy is shown to reduce mortality in adults with HIV and TB, this intervention would have one of the highest cost benefit ratios known, because adjunct Vitamin A therapy would cost about 80 cents per person and could be readily incorporated with TB chemotherapy.